Innovative Steroid Treatment to Reduce Asthma Development in Children After First-time Rhinovirus Induced Wheezing

• Status: Recruiting
• Trial end date: 2025-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The overall objective of the study is to determine the efficacy of corticosteroids in preventing recurrent wheezing and asthma in high-risk, first-time severe wheezing children with rhinovirus infection.

The secondary objectives are to determine duration and severity of each acute episode with acute expiratory breathing difficulty, the number of episodes with acute expiratory breathing difficulty, degree of pulmonary hyperreactivity and quality of life within 24 months after study entry.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Olavs Hospital
• Collaborators: Haukeland University Hospital; Helse Stavanger HF; Karolinska University Hospital; Turku University Hospital; Ullevaal University Hospital; University Hospital of North Norway; University Hospital, Akershus
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate

Criteria

Inclusion Criteria:

• admitted to pediatric acute wards in the participating hospitals in Norway, Finland, Sweden.

• referred for first severe wheezing episode, defined as first-time acute breathing difficulty with wheezing ever, appearing less than 7 days from onset of symptoms

• one or more of the following:(a) fever, (b) hypoxia (SAT O2 <= 92%), (c) retractions (inter-, subcostal), (d) prolonged expiration (on auscultation), (e) expiratory rhonchi (on auscultation)

• rhinovirus positive PCR test in nasopharyngeal secrete

• signed informed consent and expected cooperation of the patients for the treatment and follow-up must be obtained and documented according to ICH GCP, and national/local regulations.

Exclusion Criteria:

• previous episodes with wheezing, defined as a history of acute breathing difficulty with wheezing in need of treatment at a general practitioner or at hospital, or parental information about similar breathing difficulties

• gestational age <37 weeks

• chronic illness other than atopy (eczema),

• previous systemic or inhaled corticosteroid treatment,

• participation to another trial,

• varicella infection or contact during the last 2-3 weeks,

• need for intensive care unit treatment during the present infection, except for respiratory support with high flow nasal cannula ventilation,

• any reason why, in the opinion of the investigator, the patient should not participate (e.g. not able to comply with study procedures).